Device class
Class II
Regulation 866.5180
Total clearances
3
2022-07-26 → 2024-02-06
Definition
What is Calprotectin, Fecal
The device is used for the measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The device can be used as an aid in the diagnosis of inflammatory bowel disease (ibd), crohn's disease and ulcerative colitis and to differentiate ibd from irritable bowel syndrome.
Classification details
Medical specialty
Immunology
Regulation number
866.5180
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
DiaSorin, Inc.
|
1 |
0 |
2022-07-26 |
|
Bühlmann Laboratories AG |
1 |
0 |
2024-02-06 |
|
ALPCO |
1 |
0 |
2023-04-13 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 82656 |
CPT
|
— |
High
|
Immunoassay for measurement of fecal calprotectin, inflammatory marker |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2024-02-06 |
K232057 |
Bühlmann Laboratories AG
|
BÜHLMANN fCAL® turbo and CALEX® Cap |
| 2023-04-13 |
K220763 |
ALPCO
|
ALPCO Calprotectin Immunoturbidimetric Assay |
| 2022-07-26 |
K213858 |
DiaSorin, Inc.
|
LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus |